Estimating a temperature during ablation

ABSTRACT

A method for use with an intra-body probe, a distal end of which includes an ablation electrode and a temperature sensor, is described. While (i) the ablation electrode is driving an ablating current into tissue of a subject, and (ii) fluid is passed from the distal end of the intra-body probe at a fluid-flow rate, a processor receives a temperature sensed by the temperature sensor. The processor estimates a temperature of the tissue, based at least on the sensed temperature and at least one parameter selected from the group consisting of: the fluid-flow rate, and a parameter of the ablating current. The processor generates an output in response to the estimated temperature. Other embodiments are also described.

CROSS REFERENCE TO RELATED APPLICATION

This patent application is a continuation of U.S. patent applicationSer. No. 16/269,851 filed on Feb. 7, 2019 which is a divisional of U.S.patent application Ser. No. 14/998,204 filed on Dec. 24, 2015, now U.S.Pat. No. 10,213,253.

FIELD OF THE INVENTION

The present invention relates generally to invasive medical devices, andparticularly to probes used in ablating tissue within the body.

BACKGROUND

Minimally-invasive intracardiac ablation is the treatment of choice forvarious types of arrhythmias. To perform such treatment, the physiciantypically inserts a catheter through the vascular system into the heart,brings the distal end of the catheter into contact with myocardialtissue in areas of abnormal electrical activity, and then energizes oneor more electrodes at or near the distal end in order to create tissuenecrosis.

U.S. Patent Application Publication 2010/0030209, whose disclosure isincorporated herein by reference, describes a catheter with a perforatedtip, which includes an insertion tube, having a distal end for insertioninto a body of a subject. A distal tip is fixed to the distal end of theinsertion tube and is coupled to apply energy to tissue inside the body.The distal tip has an outer surface with a plurality of perforationsthrough the outer surface, which are distributed circumferentially andlongitudinally over the distal tip. A lumen passes through the insertiontube and is coupled to deliver a fluid to the tissue via theperforations.

U.S. Pat. No. 5,957,961, whose disclosure is incorporated herein byreference, describes a catheter having a distal segment carrying atleast one electrode extending along the segment and having a number oftemperature sensors arranged along the distal segment adjacent theelectrode, each providing an output indicative of temperature. Thecatheter is coupled to a power source, which provides RF energy to theelectrode. Temperature processing circuitry is coupled to thetemperature sensors and the power source, and controls power output fromthe power source as a function of the outputs of the temperaturesensors.

U.S. Pat. No. 6,312,425, whose disclosure is incorporated herein byreference, describes an RF ablation catheter tip electrode with multiplethermal sensors. A tip thermal sensor is located at or near the apex ofthe distal-end region, and one or more side thermal sensors are locatednear the surface of the proximal-end region. The electrode is preferablyan assembly formed from a hollow dome-shaped shell with a core disposedwithin the shell. The side thermal sensor wires are electricallyconnected inside the shell and the core has a longitudinal channel forthe side thermal sensor wires welded to the shell. The shell alsopreferably has a pocket in the apex of the shell, and the end thermalsensor wires pass through the core to the apex of the shell.

U.S. Pat. No. 6,217,574, whose disclosure is incorporated herein byreference, describes an irrigated split tip electrode catheter. A signalprocessor activates an RF generator to transmit a low level RF currentto each electrode member of the split tip electrode. The signalprocessor receives signals indicative of the impedance between eachelectrode member and one or more surface indifferent electrodes anddetermines which electrode members are associated with the highestimpedance. Such electrode members are stated to be those in greatestcontact with the myocardium.

U.S. Pat. No. 6,391,024, whose disclosure is incorporated herein byreference, describes a method of assessing the adequacy of contactbetween an ablation electrode and biological tissue. The method measuresthe impedance between an ablation electrode and a reference electrode ata first and second frequencies. A percentage difference between thefirst-frequency impedance and the second-frequency impedance is statedto provide an indication of the state of electrode/tissue contact.

U.S. Pat. No. 6,730,077, whose disclosure is incorporated herein byreference, describes a cryocatheter for treatment of tissue. A signalconductor extends through the catheter to the catheter tip and connectsto a thermally and electrically conductive shell or cap that applies anRF current to the region of tissue contacted by the tip. A tissueimpedance path between the signal lead and a surface electrode mountedon the patient's skin is monitored to develop a quantitative measure oftissue contact at the distal tip.

U.S. Patent Application Publication 2014/0171936 to Govari, which isincorporated herein by reference, describes apparatus that includes aninsertion tube having a distal end configured for insertion intoproximity with tissue in a body of a patient and containing a lumenhaving an electrical conductor for conveying electrical energy to thetissue. The apparatus further includes a conductive cap attached to thedistal end of the insertion tube and coupled electrically to theelectrical conductor, wherein the conductive cap has an outer surface.In addition there are a multiplicity of optical fibers contained withinthe insertion tube, each fiber terminating in proximity to the outersurface of the cap, and being configured to convey optical radiation toand from the tissue while the electrical energy is being conveyed to thetissue.

SUMMARY OF THE INVENTION

There is provided, in accordance with some embodiments of the presentinvention, a method for use with an intra-body probe, a distal end ofwhich includes an ablation electrode and a temperature sensor. While (i)the ablation electrode is driving an ablating current into tissue of asubject, and (ii) fluid is passed from the distal end of the intra-bodyprobe at a fluid-flow rate, a processor receives a temperature sensed bythe temperature sensor. The processor estimates a temperature of thetissue, based at least (i) on the sensed temperature and (ii) thefluid-flow rate and/or a parameter of the ablating current. Theprocessor generates an output in response to the estimated temperature.

In some embodiments, the at least one parameter includes a power of theablating current.

In some embodiments, estimating the temperature of the tissue includesestimating the temperature of the tissue at an interface of the tissueand the electrode.

In some embodiments, the temperature is sensed while the temperaturesensor is not in contact with the tissue.

In some embodiments, the method further includes adjusting a power ofthe ablating current in response to the output.

In some embodiments, adjusting the power of the ablating currentincludes stopping the ablating current.

In some embodiments, the method further includes changing the fluid-flowrate, in response to the output.

In some embodiments, the method further includes, in response to theoutput, changing a force with which the electrode is pressed against thetissue.

In some embodiments, estimating the temperature of the tissue includes:

selecting a coefficient in response to the at least one parameter; and

estimating the temperature of the tissue, at least by multiplying, bythe coefficient, a value that is based on the sensed temperature.

In some embodiments, selecting the coefficient includes computing thecoefficient by interpolation.

There is further provided, in accordance with some embodiments of thepresent invention, apparatus for use with an intra-body probe, a distalend of which includes an ablation electrode and a temperature sensor.The apparatus includes an interface configured to connect to theintra-body probe, and a processor. While (i) the ablation electrode isdriving an ablating current into tissue of a subject, and (ii) fluid ispassed from the distal end of the intra-body probe at a fluid-flow rate,the processor receives from the temperature sensor, via the interface, atemperature sensed by the temperature sensor. The processor estimates atemperature of the tissue, based at least on (i) the sensed temperature,and (ii) the fluid-flow rate and/or a parameter of the ablating current.The processor generates an output in response to the estimatedtemperature.

There is further provided, in accordance with some embodiments of thepresent invention, a method for use with a probe that includes anablation electrode and a temperature sensor. The method includesperforming a plurality of ablations of tissue, using the ablationelectrode. During each of the ablations, (i) fluid is passed from theprobe at a fluid-flow rate, (ii) a temperature is sensed, using thetemperature sensor, and (iii) a temperature of the tissue is measured.From the ablations, a relationship between the sensed temperatures andthe measured temperatures is learned.

In some embodiments, learning the relationship includes learning therelationship by regressing a variable that is based on the measuredtemperatures on a variable that is based on the sensed temperatures.

In some embodiments, the regressing includes performing a linearregression.

In some embodiments, performing the plurality of ablations includesperforming at least two ablations whose ablation powers differ from eachother.

In some embodiments, performing the plurality of ablations includesperforming at least two ablations that differ from each other in a forcewith which the electrode is pressed against the tissue.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic pictorial illustration of a system for cardiacablation treatment, in accordance with some embodiments of the presentinvention;

FIG. 2 shows experimental data acquired by the present inventors;

FIG. 3A is a flow diagram for a method for learning a coefficient, inaccordance with some embodiments of the present invention; and

FIG. 3B is a flow diagram for a method for estimating a temperature oftissue, in accordance with some embodiments of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS Overview

It has been found that cooling (or “irrigating”) the area of theablation site reduces thrombus (blood clot) formation. For this purpose,for example, Biosense Webster Inc. (Diamond Bar, Calif.) offers theThermoCool® irrigated-tip catheter for use with its CARTO® integratedmapping and ablation system. The metal catheter tip, which is energizedwith radio-frequency (RF) electrical current to ablate the tissue, has anumber of peripheral holes, distributed circumferentially around thetip, for irrigation of the treatment site. During the procedure, a pumpcoupled to the catheter delivers an irrigating saline solution to thecatheter tip, and the solution flows out through the holes. (In someembodiments, even while no ablating current is being passed into thetissue, the flow of irrigating fluid is maintained, e.g., at a reducedflow rate.)

When performing an ablation procedure, it is often advantageous toposition one or more temperature sensors near the tissue that is beingablated, to help provide feedback to the operating physician. Forexample, if the temperature sensors sense that the tissue is beingoverheated, the operating physician may stop the ablation procedure ormodify ablation parameters.

At least in some cases, to measure the temperature at thetissue-electrode interface as accurately as possible, the temperaturesensors would ideally be positioned such that they contact the tissue.However, due to regulatory concerns, and/or for other reasons,contacting the tissue with the temperature sensors may not be feasible.Hence, a particular challenge, when sensing the temperature of thetissue, is that a sensor that is not in contact with the tissue maysense a temperature that is lower than the actual temperature of thetissue at the tissue-electrode interface. Furthermore, regardless ofwhether the sensors are in contact with the tissue, the flow ofirrigating fluid (e.g., saline) from the ablation electrode may causethe sensors to sense a temperature that is lower than that which thesensors would have otherwise sensed. For example, the irrigating fluidmay function as a heat sink, transferring heat away from the temperaturesensors.

Embodiments of the present invention address these challenges, byproviding methods and apparatus for estimating a temperature of thetissue, at least at the tissue-electrode interface, based at least onthe sensed temperature and the flow rate of the irrigating fluid.

System Description

Reference is initially made to FIG. 1 , which is a schematic pictorialillustration of a system 20 for cardiac ablation treatment, inaccordance with an embodiment of the present invention. An operator 28(such as an interventional cardiologist) inserts an intra-body probe,such as a catheter 22, via the vascular system of a patient 26, into achamber of the patient's heart 24. For example, to treat atrialfibrillation, the operator may advance the catheter into the left atriumand bring a distal end 30 of the catheter into contact with myocardialtissue that is to be monitored and/or ablated.

Catheter 22 is connected at its proximal end to a console 32. Console 32comprises an RF energy generator 34, which supplies electrical power viacatheter 22 to distal end 30 in order to ablate the target tissue. Aprocessor 52 tracks the temperature of the tissue at distal end 30 byprocessing the outputs of temperature sensors in the distal end, asdescribed below. An irrigation pump 38 supplies an irrigating fluid,such as saline solution, through catheter 22 to distal end 30. Inaddition, in some embodiments, an optical module 40 provides opticalradiation, typically from, but not limited to, a laser, an incandescentlamp, an arc lamp, or a light emitting diode (LED), for transmissionfrom distal end 30 to the target tissue. The module receives andanalyzes optical radiation returning from the target tissue and acquiredat the distal end.

On the basis of information provided by the temperature sensors and/oroptical module 40, processor 52 may control the power applied by RFenergy generator 34 and/or the flow of fluid provided by pump 38, eitherautomatically or in response to inputs from operator 28, as furtherdescribed hereinbelow.

System 20 may be based on the above-mentioned CARTO system, for example,which provides extensive facilities to support navigation and control ofcatheter 22.

Distal end 30 of catheter 22 includes an ablation electrode 46, whichincludes a distal face 58. Typically, when performing the ablation, aportion of ablation electrode 46 (e.g., distal face 58) is brought intocontact with (e.g., pressed against) the tissue that is to be ablated,and subsequently, radiofrequency energy, supplied by RF energy generator34, is applied to the tissue by the ablation electrode. As shown in FIG.1 , ablation electrode 46 may be shaped to define a plurality ofperforations 60. During the procedure, irrigating fluid, supplied byirrigation pump 38, is passed from perforations 60. The passing of theirrigating fluid may help prevent blood clots from forming, by coolingand diluting the blood in the vicinity of the ablation site.

As shown in the figure, a plurality of temperature sensors 48 (e.g.,thermocouples) are disposed at various respective positions on and/orwithin ablation electrode 46. In particular, the “head-on” view ofdistal face 58 shows three circumferentially-arranged temperaturesensors 48 near the distal face 58 of the electrode, each of thetemperature sensors being contained within a lumen in the wall of theelectrode. The isometric view of distal end 30, which “cuts away” theouter wall of one of the lumens, shows two temperature sensors withinthe lumen—(i) a distal temperature sensor 48 a, which is one of thethree sensors shown in the distal-end view, and (ii) a proximaltemperature sensor 48 b, which is one of three proximal sensors that arenot shown in the distal-end view. Distal end 30, as shown in FIG. 1 ,thus comprises a total of six temperature sensors. (Notwithstanding theabove, it is noted that the scope of the present disclosure includes theuse of any suitable number and arrangement of temperature sensors.)

While the ablation electrode is used to drive an ablating current intothe tissue, and while the irrigating fluid is passed from the distal endof the catheter (e.g., through perforations 60), one or more of thetemperature sensors are used to sense respective temperatures.

In general, it is advantageous to have a plurality of temperaturesensors disposed at various locations with respect to the tissue, e.g.,in that information regarding the orientation of the ablation electrodemay be deduced from the various temperature readings provided by thesensors. For example, if each of the three distal sensors sensesapproximately the same temperature (indicating that the three distalsensors are approximately equidistant from the tissue), and/or if eachof the three proximal sensors senses approximately the same temperature(indicating that the three proximal sensors are approximatelyequidistant from the tissue), it may be deduced that the electrode isoriented perpendicularly with respect to tissue, as is typicallydesired. Conversely, if, for example, one of the proximal sensors sensesa temperature that is higher than that sensed by the other two proximalsensors, it may be deduced that the ablation electrode is not orientedperpendicularly with respect to the tissue, such that one of theproximal sensors is closer to the tissue than the other proximalsensors.

Aside from providing information concerning the orientation of thecatheter, the temperature sensors may facilitate the performance of theablation, by indicating whether the tissue at the tissue-electrodeinterface is at the desired temperature for ablation. However, as notedabove, a temperature sensor that is not in contact with the tissue maysense a temperature that is lower than the actual temperature of thetissue at the tissue-electrode interface. For example, distal sensor 48a may be disposed somewhat proximally to distal face 58, such thatdistal sensor 48 a is generally not in contact with the tissue duringthe ablation procedure. Consequently, the temperature sensed by distalsensor 48 a is typically lower than the actual temperature of the tissueat the interface. The difference between the actual temperature and thesensed temperature is typically even greater for proximal sensor 48 b,which is farther from the tissue than distal sensor 48 a.

Furthermore, as noted above, the flow of irrigating fluid fromperforations 60 causes the respective sensed temperatures from at leastsome of the temperature sensors to be lower, relative to if noirrigating fluid were flowing from perforations 60. To address the abovechallenges, embodiments of the present invention provide apparatus andmethods for estimating the actual temperature of the tissue, at least atthe tissue-electrode interface, as described immediately hereinbelow.

Reference is now made to FIG. 2 , which shows experimental data acquiredby the present inventors. As further described below, the experimentaldata of FIG. 2 shows the relationship between the temperature sensed bythe temperature sensors and the “actual” measured temperature of thetissue.

To acquire the data, distal end 30 was used to “ablate” ex vivo tissuemultiple times. During each of the trial ablations, irrigating fluid waspumped out of the distal end, multiple temperature sensors in the distalend of the catheter were used for sensing, and additionally, athermometer was used to measure the actual temperature of the tissue atthe tissue-electrode interface. Two sets of trial ablations wereconducted; a first set with an irrigating-fluid flow rate of 8 mL/min,and a second set with an irrigating-fluid flow rate of 15 mL/min. Thetrial ablations of each set were conducted with different respectiveablation powers, and/or different respective forces of contact betweenthe electrode and the tissue. (Each of these factors affects thetemperature at the tissue-electrode interface; for example, increasingthe power, and/or increasing the force of contact, increases thetemperature.)

Sensed temperature values ST, minus a normalizing temperature T_0(described below), are plotted along the horizontal axis of FIG. 2 . Inthis particular case, the sensed temperature values ST are the averageof the temperatures sensed by the three distal temperature sensors,shown in FIG. 1 . The thermometer reading TR, minus T_0, is plottedalong the vertical axis. Each point in FIG. 2 thus represents a pair ofvalues (ST-T_0, TR-T_0) for a particular flow rate, ablation power, andforce of contact. Typically, a flow rate of 15 mL/min is used only for arelatively high ablation power and/or force of contact; hence, the datafor 15 mL/min includes only relatively high temperatures.

As shown in FIG. 2 , for each of the flow rates, a linear regressionfunction was fit to the acquired data with a high goodness of fit, asevidenced by the high “R-squared” values. This regression function maybe expressed in the form TR-T_0=a(FR)*(ST-T_0), where T_0, ST, and TRare as described above, and a(FR) is a coefficient that is a function ofthe flow rate of the irrigating fluid. In particular, for a flow rate of8 mL/min, FIG. 2 shows a coefficient a(FR) of around 1.6, while for aflow rate of 15 mL/min, FIG. 2 shows a coefficient a(FR) of around 2.

T_0 is the value of ST prior to the start of the ablation, e.g., theaverage temperature sensed over the one second prior to the start of theablation. Prior to the start of the ablation, TR is typically the sameas ST, such that ST=TR=T_0. Hence, the subtraction of T_0 from each ofST and TR, prior to performing the regression, typically simplifies theregression, by causing each of the regressed lines to pass through theorigin. Stated differently, the regression is simplified, in that theregression function includes only one variable (i.e., a(FR)), ratherthan two variables. Notwithstanding the above, it is noted that theregressions depicted in FIG. 2 may be performed even without measuringor using T_0; the measurement and use of T_0 is generally forconvenience only.

In any case, the “X” variable in the regression is typically a variablethat is based on ST. For example, this variable may be ST itself, orST-T_0, as described above. Similarly, the “Y” variable in theregression is typically a variable that is based on TR. For example,this variable may be TR itself, or TR-T_0, as described above.

As further described hereinbelow, the regression function illustrated inFIG. 2 may be used to estimate the temperature of the tissue, at leastat the tissue-electrode interface, during a live ablation procedure.

As noted above, the trials depicted in FIG. 2 were conducted with TRmeasured at the electrode-tissue interface. In some cases, during a liveprocedure, it may be advantageous to estimate the temperature of thetissue at deeper locations within the tissue, e.g., 5 mm beneath thetissue. Hence, the scope of the present invention includes (i)performing ablations (e.g., trial ablations) with TR measured at suchdeeper locations, thus allowing respective regression functions to bedetermined for these locations, and (ii) during a live procedure, usingthe regression functions to estimate the temperature of the tissue atthese locations.

In some embodiments, the flow of irrigation fluid roughly affects asubset of, or all of, the temperature sensors in a similar way, suchthat a(FR) may be learned by averaging the sensed temperatures over thesubset of, or all of, the sensors. For example, as noted above, thesensed temperatures shown in FIG. 2 are averages for the three distalsensors, and a single a(FR) is learned for the three distal sensors. Inother embodiments, a(FR) may be learned separately for each of one ormore of the sensors. FIG. 3A, described immediately hereinbelow,describes such an embodiment.

Reference is now made to FIG. 3A, which is a flow diagram for a method62 for learning a (FR), in accordance with some embodiments of thepresent invention. In method 62, a(FR) is learned for one or more flowrates, for each of one or more temperature sensors. For each sensor andflow rate, a(FR) is learned, at a learning step 64, using the techniquedescribed above with reference to FIG. 2 . In other words, at learningstep 64, distal end 30 is used to “ablate” ex vivo tissue using variousablation powers and/or contact forces, while irrigating fluid is pumpedout of the distal end. Sensed temperatures and actual temperatures areacquired, and regression (e.g., linear regression) is used to learna(FR).

In general, since the flow rate of the irrigation fluid may vary overdifferent ablation procedures, and/or may vary during a single ablationprocedure, it may be advantageous to learn a(FR) for more than one flowrate. For example, various flow rates within the range of 8-15 mL/minmay be of interest, since, during a live procedure, the flow rate istypically between 8 mL/min and 15 mL/min.

For example, a(FR) may first be learned, at learning step 64, for sensor48 a (FIG. 1 ) and a flow rate of 8 mL/min. Subsequently, at a firstdecision step 66, a decision is made as to whether to change the currentflow rate. If the decision is made to change the current flow rate(e.g., to 15 mL/min), the current flow rate is changed, at aflow-rate-changing step 67. Subsequently, at learning step 64, a(FR) islearned for the second flow rate.

Once a(FR) has been learned for all of the flow rates of interest,method 62 proceeds to a second decision step 68, at which a decision ismade as to whether to change the current sensor. If a decision is madeto change the current sensor (e.g., to sensor 48 b (FIG. 1 )), thesensor is changed at a sensor-changing step 69. Subsequently, atlearning step 64, a(FR) is learned for the second sensor, for all of theflow rates of interest.

Method 62 ends once a(FR) has been learned for all of the sensors andflow rates of interest.

The inventors have observed that the relationship between the sensedtemperature and the measured temperature is often alternatively oradditionally dependent on a parameter of the ablating current, such asthe power of the ablating current (“ablation power”). Hence, in someembodiments, the learned coefficient “a” is dependent on one or morevariables, such as the ablation power, instead of or in addition to theflow rate. Nonetheless, for simplicity, the notation “a(FR)” is usedthroughout the description, even if the learned coefficient “a” isactually a function of one or more variables instead of or in additionto the flow rate “FR”.

Reference is again made to FIG. 1 , and is additionally made to FIG. 3B,which is a flow diagram for a method 49 for estimating a temperature oftissue, in accordance with some embodiments of the present invention.Whereas method 62 is typically (but not necessarily) practiced ex vivoand “offline,” method 49 is practiced in vivo, during a live ablationprocedure.

Method 49 begins with an initial-sensing step 70, at which T_0 issensed. (Typically, an average over several of the sensors is used forT_0.) Subsequently, at an ablation-beginning step 74, the operatingphysician begins to perform the ablation. As shown in FIG. 1 , system 20comprises an interface 50 (e.g., a connector and/or port), and aprocessor 52. Interface 50 is configured to connect to distal end 30 ofcatheter 22 (e.g., via a wire running through the catheter), and tofacilitate communication between the distal end of the catheter andprocessor 52. Through interface 50, processor 52 receives, at areceiving step 51, the respective temperatures (“ST”) sensed by sensors48 during the ablation procedure. The processor may average thesetemperatures over a subset of the sensors, or over all of the sensors.

In some embodiments, the processor further receives, at receiving step51, the fluid-flow rate of the irrigating fluid, e.g., by receiving thefluid-flow rate directly from pump 38. Alternatively or additionally,the processor may receive, at receiving step 51, a parameter of, such asthe power of, the ablating current that is output from RF energygenerator 34. For example, the processor may receive a signal from theRF generator, or from a measuring device, that indicates the power ofthe ablating current. In other embodiments, as described below, theprocessor controls the pump and/or the RF generator, such that theprocessor generally “knows” the fluid-flow rate and/or theablating-current parameter even without the performance of receivingstep 51.

Subsequently, at an estimation step 53, the processor estimates thetemperature of the tissue in the vicinity of electrode 46 (e.g., at thetissue-electrode interface), based at least on (i) one or more of thesensed temperatures (e.g., based on one or more averages of the sensedtemperatures), and (ii) the fluid-flow rate of the irrigating fluidand/or the parameter of the ablating current. For example, based on (i)a particular one of the temperatures ST sensed by one of the sensors,and (ii) the corresponding a(FR) value, the processor may compute anestimated temperature (“ET”) of the tissue, by applying the equationET=a(FR)*(ST-T_0)+T_0. (This equation is equivalent to the regressionfunction described above, with the notation “ET” used in place of “TR.”)In other words, the processor selects (i.e., computes, or selects from alookup table) the appropriate a(FR) for the sensor in response to theflow rate and/or ablating-current parameter, multiplies ST-T_0 by theselected a(FR), and adds T_0, to arrive at the estimated temperature.

In some embodiments, a model is fit to the experimentally-derived valuesof a(FR). In such embodiments, a coefficient a(FR) that is interpolatedfrom the experimentally-derived coefficients may be selected for thetemperature estimation. For example, using linear interpolation, for thevalues shown in FIG. 2 , the selected a(FR) would be approximately 1.7for a flow rate of 10 mL/min. Alternatively, extrapolation may be usedto select a(FR).

Typically, the processor performs a respective estimate for each of thesensed temperatures or averages of the sensed temperatures, and averagesthe respective estimates to arrive at a “combined” estimate. Forexample, with reference to FIG. 1 , the processor may perform a firstestimate for the three distal sensors and a second estimate for thethree proximal sensors, and compute the combined estimate by averagingthe two separate estimates.

Subsequently, in response to the estimated temperature (e.g., thecombined estimate), at an output-generating step 55, the processorgenerates an output, such as a visual output 57 that indicates theestimated temperature. (Visual output 57 may be shown on a userinterface 56, which includes, for example, a touch screen.) In responseto the output, operator 28 may adjust the power of the ablating currentsupplied by RF energy generator 34, e.g., by stopping the ablatingcurrent, or by otherwise decreasing the power of the current.Alternatively or additionally, in response to the output, the operatormay change the rate of flow of irrigating fluid supplied by pump 38, orchange the contact force with which the electrode is pressed against thetissue.

In some embodiments, the operator controls RF energy generator 34 and/orpump 38 via processor 52. In such embodiments, the operator typicallyprovides input to the processor, such as by using user interface 56. Inresponse to the input, the processor generates a control signal 59 thatcontrols the RF energy generator and/or the pump. In other embodiments,processor 52 automatically controls the RF energy generator and/or pump,i.e., the output that is generated in output-generating step 55 includescontrol signal 59.

Typically, method 49 is repeatedly performed during the ablationprocedure, i.e., steps 51, 53, and 55 are repeatedly performed insequence, such that patient 26 is continually monitored during theprocedure.

In general, processor 52 may be embodied as a single processor, or as acooperatively networked or clustered set of processors. Processor 52 istypically a programmed digital computing device comprising a centralprocessing unit (CPU), random access memory (RAM), non-volatilesecondary storage, such as a hard drive or CD ROM drive, networkinterfaces, and/or peripheral devices. Program code, including softwareprograms, and/or data are loaded into the RAM for execution andprocessing by the CPU and results are generated for display, output,transmittal, or storage, as is known in the art. Such program codeand/or data, when provided to the processor, produce a machine orspecial-purpose computer, configured to perform the tasks describedherein.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description. Documents incorporatedby reference in the present patent application are to be considered anintegral part of the application except that to the extent any terms aredefined in these incorporated documents in a manner that conflicts withthe definitions made explicitly or implicitly in the presentspecification, only the definitions in the present specification shouldbe considered.

The invention claimed is:
 1. A method for use with an intra-body probe,a distal end of which includes an ablation electrode and a temperaturesensor, the method comprising, using a processor: receiving an initialtemperature sensed by the temperature sensor before the ablationelectrode drives an ablating current into tissue of a subject; receivinga temperature sensed by the temperature sensor while the ablationelectrode is driving an ablating current into tissue of a subject, andfluid is passed from the distal end of the intra-body probe at a fluidflow rate; calculating an estimated temperature of the tissue in thevicinity of the electrode during ablation by adding to the initialsensed temperature, the difference between the sensed temperature duringablation and the initial sensed temperature multiplied by a coefficientselected based on at least one of the fluid flow rate or a parameter ofablating current added to the initial sensed temperature; and generatingan output in response to the estimated temperature.
 2. The methodaccording to claim 1, wherein calculating the estimated temperature ofthe tissue comprises calculating the estimated temperature of the tissueat an interface of the tissue and the ablation electrode.
 3. The methodaccording to claim 1, wherein the temperature is sensed during ablationwhile the temperature sensor is not in contact with the tissue.
 4. Themethod according to claim 1, further comprising adjusting a power of theablating current in response to the output.
 5. The method according toclaim 4, wherein adjusting the power of the ablating current comprisesstopping the ablating current.
 6. The method according to claim 1,further comprising changing the fluid flow rate, in response to theoutput.
 7. The method according to claim 1, further comprising, inresponse to the output, changing a force with which the ablationelectrode is pressed against the tissue.
 8. The method according toclaim 1, wherein selecting the coefficient comprises computing thecoefficient by interpolation.
 9. An apparatus for use with an intra-bodyprobe, a distal end of which includes an ablation electrode and atemperature sensor, the apparatus comprising: an interface configured toconnect to the intra-body probe; and a processor configured to: receivean initial temperature sensed by the temperature sensor before theablation electrode drives an ablating current into tissue of a subject;receive a temperature sensed by the temperature sensor while theablation electrode is driving an ablating current into tissue of asubject, and fluid is passed from the distal end of the intra-body probeat a fluid flow rate, calculate an estimated a temperature of the in thevicinity of the electrode during ablation by adding to the initialsensed temperature, the difference between the sensed temperature duringablation and the initial sensed temperature multiplied by a coefficientselected based on at least one of the fluid flow rate or a parameter ofablating current added to the initial sensed temperature; and generatean output in response to the estimated temperature.
 10. The apparatusaccording to claim 9, wherein the processor is configured to calculatethe estimated temperature of the tissue at an interface of the tissueand the ablation electrode.
 11. The apparatus according to claim 9,wherein the processor is configured to, by generating the output, adjusta power of the ablating current.
 12. The apparatus according to claim11, wherein the processor is configured to, by generating the output,stop the ablating current.
 13. The apparatus according to claim 9,wherein the processor is configured to, by generating the output, changethe fluid-flow rate.